Registration Dossier
Registration Dossier
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EC number: 222-314-9 | CAS number: 3423-25-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 April - 01 August 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Endo-8-isopropyl-8-azabicyclo[3.2.1]octan-3-ol
- EC Number:
- 222-314-9
- EC Name:
- Endo-8-isopropyl-8-azabicyclo[3.2.1]octan-3-ol
- Cas Number:
- 3423-25-4
- Molecular formula:
- C10H19NO
- IUPAC Name:
- Endo-8-isopropyl-8-azabicyclo[3.2.1]octan-3-ol
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- New Zealand White rabbits Crl: KBL (NZW) BR
- 3 female animals were used.
- The animals were derived from a controlled full barrier maintained breeding system (spf)
- Source: Harlan Winkelmann GmbH, D-33178 Borchen.
- According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals were bred for experimental purposes.
CONDITIONS
- Semi-barrier in air conditioned rooms.
- Temperature: 18 ± 3° C
- Rel. humidity: 55 ± 10%
- Artificiallight, lighting regime 12 : 12 hours, light 6.30 - 18.30
- Air change: 10 x / hour.
- Free access to Altromin 2123 maintenance diet for rabbits, rich in crude fibre, totally-pathogen-free (TPF).
- Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically).
- House in ABS - plastic rabbit cages, floor 4200 cm^2
- Adequate acclimatization period.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- not specified
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 g of the test item was applied to each test site
- Duration of treatment / exposure:
- 4h
- Observation period:
- 72h
- Number of animals:
- 3
- Details on study design:
-Preparation of the test item was moistened with Aqua ad inj., to ensure good contact
- To prepare test animals, approximately 24 hours before the test, fur was removed from the dorsal area of the trunk by clipping.
-The test item was applied in a single dose to a small area (approx. 6cm^2) of skin on one side of the dorsal area with a gauze patch, which was held in place with non-irritating tape.
The other side served as control. The test item was applied to the patch first, and then applied to the skin. The patch was fixed with a semi-occlusive dressing.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Considering the reported data of this irritation study it can be stated that the test item N-Isopropylnortropin showed no irritant/corrosive effects
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